Over the years, various apparatuses and devices have been developed for the purpose of introducing and removing fluids from bodies, such as the human body. Examples of such devices include catheters, shunts, drainage tubes, and other tubular medical devices as known in the art, broadly referred to hereafter as “catheters.” Such catheters may be positioned in various locations within a body and, once in place, may be anchored by a stabilizing device.
One example of a conventional catheter stabilizing device is a tissue-ingrowth cuff. Tissue-ingrowth cuffs are typically made of a biocompatible fabric, such as polyester, and are typically attached to the outer surface of a catheter or cannula by an adhesive. In many conventional catheters, the cuff is positioned on the catheter such that when the distal portion of the catheter is fully inserted into the body, the cuff is located in subcutaneous tissue, such as a subcutaneous tunnel. A subcutaneous tunnel such as this can be formed by a tunneling tool, such as a trocar, either before or after inserting the distal end of the catheter into a bodily cavity, duct, vessel, or the like. The proximal portion of the catheter having the cuff may then be drawn through the tunnel by the tool while the tool passes through the subcutaneous tissue. In many conventional catheters, an adhesive is applied to the cuff fabric to matte the fabric in an attempt to reduce the amount of force needed to tunnel the catheter. The stabilizing cuff is also typically sized such that upon completion of the catheterization procedure, the cuff fits snugly in the tunnel or other area.
Upon completion of the catheterization procedure, surrounding tissue in the body grows into the biocompatible fabric of the cuff to further stabilize the catheter in the catheterized location. In addition to stabilizing the catheter, the ingrown tissue helps to seal off the catheterized location and subcutaneous tunnel from foreign bodies, which may also prevent patient infection. Ingrown tissue may also prevent blood from exiting or pooling around the catheter near the exit site.
Although conventional fabric cuffs are inexpensive to make and are generally effective at stabilizing a catheter, difficulty remains in inserting and removing such cuffs into/from a patient. Specifically, because adhesive is used to affix conventional cuffs to the catheter, the ultimate size and profile of the cuff structure (and catheter assembly) may be adversely increased based on the amount and thickness of the adhesive used, which may vary. The integrity of conventional cuff structures is also at least partially dependent on, and may be weakened by, the adhesive bond formed between the cuff structure and the catheter. In addition, the adhesive used to matte the cuff fabric may impede tissue ingrowth or result in a rigid, inflexible cuff structure.
Accordingly, there is a need for a robust stabilizing device that improves upon the prior art. There is also need for improved methods of manufacturing cuff structures.